Regulation – VJRegenMed

Optimizing the upscaling and outscaling of CAR T-cell therapies

Thu, 14 Apr 2022 15:56:43 +0000

Saskia Rösch, PhD, Miltenyi Biotec, Bergisch Gladbach, Germany, describes novel approaches to enhance chimeric antigen receptor (CAR) T-cell manufacturing. Upscaling can incur cost-related barriers, especially for T-cell receptor (TCR) and allogeneic therapies in solid tumor indications, and utilizing non-viral vectors as well as reducing the cultivation time may ameliorate the aforementioned issues. Developers additionally face issues in outscaling due to complications in material and documentation management, and Dr Rösch suggests decentralization as a potential solution. Regulatory authorities must also collaborate to expedite the development of T-cell therapies. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

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The importance of collaboration in cell and gene therapy development

Thu, 24 Feb 2022 11:16:28 +0000

Delara Motlagh, PhD, MS, EMBA, Terumo Blood and Cell Technologies, Lakewood, CO, provides an overview on the significance of reinforcing collaboration and harmonization across different stakeholders involved in the development of advanced therapies. Due to the complexity and novelty of cell and gene therapies, multiple stakeholders are required throughout the development process from logistics to regulatory approval. Dr Motlagh additionally highlights existing collaborative efforts between academia and industry, where academic institutions can foster innovation and pharmaceuticals enable the commercialization of products. This interview took place at Advanced Therapies Week 2022.

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Improving the scalability of advanced therapies

Thu, 24 Feb 2022 11:16:27 +0000

Delara Motlagh, PhD, MS, EMBA, Terumo Blood and Cell Technologies, Lakewood, CO, comments on the challenges in scaling-up cell and gene therapy manufacturing. Flexibility in the initial process development of the product is vital to make changes that may be needed in later stages of production. Dr Motlagh also emphasizes the role automation plays in expediting the manufacturing process, especially towards the final stages, as well as in facilitating regulatory approval of the therapies. Platforms that provide closed and Good Manufacturing Practice compliant systems will additionally be crucial to scale-up the commercialization of advanced therapies. This interview took place at Advanced Therapies Week 2022.

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Strategies for large scale viral vector development

Fri, 18 Feb 2022 15:46:05 +0000

Rachel Legmann, PhD, Repligen, Waltham, MA, gives her perspectives on how to successfully develop viral vectors, including the need to have scalable process ready for commercialization. Dr Legmann additionally emphasizes the importance of the product meeting existing regulatory guidelines, especially before mass manufacturing, as well as choosing a suitable platform that can flexibly switch between different modalities, as the formulation will only need to be altered in such circumstances. This interview took place at Advanced Therapies Week 2022.

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Building collaborative relationships to overcome challenges in the CGT industry

Thu, 03 Feb 2022 12:25:11 +0000

Sharon Brownlow, PhD, Cell and Gene Therapy Catapult, London, UK, talks on the importance of collaborating between different stakeholders across academia, healthcare and industry in order to overcome barriers in the cell and gene therapy (CGT) space. Dr Brownlow comments on a consortium created by Cell and Gene Therapy Catapult to help maintain confidentiality, and supporting companies in their manufacturing process. Dr Brownlow additionally highlights the benefits of harnessing the power of pre-competitive collaboration. This interview took place at Advanced Therapies Week 2022.

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Regulatory challenges in automating CGT manufacturing

Thu, 03 Feb 2022 10:27:41 +0000

Delara Motlagh, PhD, MS, EMBA, Terumo Blood and Cell Technologies, Lakewood, CO, discusses hurdles associated with automating processes within the cell and gene therapy (CGT) field. Despite collaborative efforts between manufacturers and regulatory authorities, supply chain issues persist. Dr Motlagh additionally highlights the need for companies to fully understand every aspect of their current and future products. This interview took place at Advanced Therapies Week 2022.

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The role of ARM in the cell and gene therapy industry

Thu, 03 Feb 2022 10:27:39 +0000

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., describes the influence of ARM in the cell and gene therapy (GCT) industry and future plans for ARM within the sector. The A-Gene and A-Cell projects have been providing guidance to companies and academic institutions. Collaboration with the FDA and EMA, as well with the network of manufacturers and industry experts have additionally proven useful to address Chemistry, Manufacturing and Controls (CMC) issues. This interview took place at Advanced Therapies Week 2022.

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The impact of COVID-19 on the advanced therapy sector

Tue, 01 Feb 2022 18:03:40 +0000

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., provides an overview of how the cell and gene therapy (GCT) industry has adapted to the COVID-19 pandemic. Overall, the industry has shown resilience to the pandemic, with clinical trials successfully adapting to the change in circumstances. The advent of remote working has additionally increased the pool of available workers, and remote inspections by regulatory authorities may positively impact the regulatory process. This interview took place at Advanced Therapies Week 2022.

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Clinical challenges in developing AAV-based gene therapies

Tue, 01 Feb 2022 18:03:38 +0000

Adeno-associated virus (AAV) vectors have become pivotal in the clinical development of gene therapies. Christopher Reardon, Dyno Therapeutics, Cambridge, MA, describes challenges associated with using AAV vectors, including regulatory barriers. Despite a small number of gene therapies successfully being approved, the pathway for regulating this novel technology requires consolidation and optimization. This interview took place at Advanced Therapies Week 2022.

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Achieving operational excellence in CGT through automation

Mon, 31 Jan 2022 17:59:03 +0000

Sharon Brownlow, PhD, Cell and Gene Therapy Catapult, London, UK, discusses the challenges in achieving operational excellence in the cell and gene therapy (CGT) field and strategies to overcome these challenges. Achieving operational excellence is necessary as the timeframe to release a product is very limited, but is challenging due to the highly complex process of manufacturing CGTs. Whilst automation will have a dramatic impact in improving operational excellence, many of the systems currently used in CGT are not tailored to early product development. Dr Brownlow additionally highlights how many companies are integrating processes together and developing more configurable systems, as well as ‘factory-in-a-box’ technologies which can manufacture multiple CGTs simultaneously in a fully automated fashion. This interview took place at Advanced Therapies Week 2022.

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